LEDEX
Device Facts
| Record ID | K221194 |
|---|---|
| Device Name | LEDEX |
| Applicant | Dentmate Technology Co. , Ltd. |
| Product Code | EBZ · Dental |
| Decision Date | Sep 16, 2022 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 872.6070 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
LEDEX WL-120 is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.
Device Story
LEDEX WL-120 is a visible light curing unit used by dental professionals in clinical settings to polymerize dental materials. The device utilizes a 10W LED light source with four curing chips (peak wavelengths 405 nm and 460 nm) to emit light through an optical fiber guide rod. It features a thermal management system with a heat sink and over-temperature protection circuits to ensure safety and consistent performance. The device is powered by a 3.7V rechargeable Li-ion battery. Operational modes include Low, Ramp, Standard, High, Turbo, Plasma, and White. The device includes an automatic memory function for the last operation group. Clinicians operate the handpiece to direct light onto dental composites; the resulting polymerization hardens the material, facilitating dental restorative procedures.
Clinical Evidence
Bench testing only. Performance evaluated via optical power testing, spectral irradiance plots, and composite hardness (depth of cure) testing. Testing conducted in accordance with ANSI/ADA Specification No. 48-2:2010, ANSI/ADA Specification No. 48:2020, and FDA guidance for dental curing lights. Results confirmed the device meets all performance specifications and safety standards.
Technological Characteristics
10W LED light source; peak wavelengths 405/460 nm; max intensity 3200 mW/cm². Outer casing: ABS plastic. Power: 3.7V Li-ion battery. Optical fiber light guide. Thermal management: heat sink with over-temperature protection. Standards: IEC 60601-1:2005 (electrical safety), IEC 60601-1-2:2014 (EMC), ISO 10650:2015 (polymerization activators).
Indications for Use
Indicated for polymerization of dental light-cured materials by dental professionals.
Regulatory Classification
Identification
An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.
Predicate Devices
- LEDEX WL-090/WL-090+ (K131042)
Submission Summary (Full Text)
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September 16, 2022
Dentmate Technology Co. Ltd. Cheng-Feng Chou President 8F, No.8-11, Sec. 1, Zhongxing Road, Wugu District. New Taipei, 24872 Taiwan
Re: K221194
Trade/Device Name: LEDEX WL-120 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: July 11, 2022 Received: July 18, 2022
Dear Cheng-Feng Chou:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael E. Adjodha, M. ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K221194
Device Name LEDEX WL-120
Indications for Use (Describe)
LEDEX WL-120 is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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### K221194
# 510(k) Summary
### Date: 04/21/2022
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
# 1. Applicant/Submitter
DENTMATE TECHNOLOGY CO., LTD. Registration Number: 3007662989 Address: 8F, No. 8-11, Sec. 1, Zhongxing Road, Wugu District, New Taipei City, 24872 Taiwan TEL: +886 2 8976 9226 Fax: +886 2 8976 9236 Email: info@dentmate.com.tw
# 2. Official/Submission correspondent
Mr. Cheng-Feng Chou Address: 8F, No. 8-11, Sec. 1, Zhongxing Road, Wugu District, New Taipei City, 24872 Taiwan TEL: +886 2 8976 9226 Fax: +886 2 8976 9236 Email: info@dentmate.com.tw
# 3. Device Information
Common Name: LED Dental Curing Light Device Trade Name: LEDEX Model Number: WL-120 Classification name: Ultraviolet Activator for Polymerization Device class: II Panel: Dental Product Code: EBZ Regulation Number: 872.6070
#### Indications for use ব
LEDEX WL-120 is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.
## 5. Predicate device
LEDEX WL-090/WL-090+, (K)131042 by DENTMATE TECHNOLOGY CO., LTD.,
## 6. Description of device
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The LEDEX WL-120 device using highly efficient LEDs with a thermal management system, while maintaining consistent performance even in the most challenging and demanding curing needs. The light has four LED curing chips with a range of 390 nm, thus effectively curing all composites.
About the light guide rod, it is made of genuine optical fiber which can optimize light conduction and minimize loss of light from source to tip. It therefore ensures the most possible intensity of light at the light guide tip.
Furthermore, we design advanced efficient cooling heat sink which accompanies with over temperature protection. The thermal protection circuits prevent the light from overheating and help to keep the device in a safety mode. Automatic memorizing the last group of operation is another unique feature of this device.
## 7. Substantial Equivalence
LEDEX WL-120 is substantially equivalent to the predicate devices LEDEX WL-090+ (K)131042 by DENTMATE TECHNOLOGY CO., LTD. in terms of intended use, technology and principle of operation.
The following comparison table is presented to demonstrate substantial equivalence.
| Descriptive<br>Information | Subject Device | Predicate device |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name and<br>model number | LEDEX WL-120 | LEDEX WL-090/WL-090+ |
| Manufacturer | DENTMATE TECHNOLOGY CO.,<br>LTD. | DENTMATE TECHNOLOGY CO.,<br>LTD. |
| 510(k) number | -- | K131042 |
| Product Code | EBZ | EBZ |
| Regulatory<br>Class | II | II |
| Indications for use | LEDEX WL-120 is a visible curing unit<br>programmed for polymerization of<br>dental light cured materials by dental<br>professionals. | LEDEX (Family model: WL-090,<br>WL-090+) is a visible curing unit<br>programmed for polymerization of<br>dental light cured materials by dental<br>professionals. |
| Device Design –<br>Operational modes | Low, Ramp, Standard, High, Turbo,<br>Plasma, White | Low, Ramp, Standard, High, Fast<br>Ortho, Turbo, Plasma |
| | | |
| Device Design -<br>Light source | 10W LED | 10W LED |
| Device Design -<br>Power source | 3.7V Rechargeable Li-ion battery | 3.7V Rechargeable Li-ion battery |
| Device Design -<br>Power supply | Input: AC100~240V, 50/60Hz<br>Output: DC 5V/2A | Input: AC100~240V, 50/60Hz<br>Output: DC 5V/2A |
| Device Design -<br>Accessories | Handpiece, Power supply, Optical<br>fiber light guide rod, Filter, Light guide<br>sleeves, Cradle, Anti-glare shield | Handpiece, Power supply, Optical<br>fiber light guide rod, Filter, Light guide<br>sleeves, Cradle, Anti-glare shield |
| Composition of<br>Materials -<br>outer casing | ABS plastic material | ABS plastic material |
| Technical<br>Specifications -<br>Light intensity | MAX. 3200 mW/cm² | MAX. 3200 mW/cm² |
| Technical<br>Specifications -<br>Peak wavelength | 405 & 460 nm | 405 & 460 nm |
| FDA-Recognized<br>Standards -<br>Electrical safety | IEC 60601-1:2005 (Third Edition) +<br>CORR. 1:2006 + CORR. 2:2007<br>+ A1:2012 (or IEC 60601-1: 2012<br>reprint)<br>ISO 10650:2015 Dentistry - Powered<br>polymerization activators | IEC 60601-1:1988, Medical Electrical<br>Equipment - Part 1: General<br>Requirements for Safety; including<br>Amendment 1(1991) and Amendment<br>2(1995). |
| FDA-Recognized<br>Standards -<br>Electromagnetic<br>compatibility | IEC 60601-1-2: 2014, Medical<br>electrical equipment - Part 1-2:<br>General requirements for basic safety<br>and essential performance - Collateral<br>Standard: Electromagnetic<br>disturbances - Requirements and tests<br>ISO 10650:2015 Dentistry - Powered<br>polymerization activators | IEC 60601-1-2, (Second Edition,<br>2001), Medical electrical equipment -<br>Part 1-2: General requirements for<br>safety; Electromagnetic Compatibility -<br>Requirements and tests. |
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### 7.1 The same between subject device and predicate device:
- a) Product Code, Regulatory Class and Manufacturer
- b) Indications for use
- c) Light source, Power supply and Accessories
- d) Outer casing material
- e) Light intensity and Peak wavelength
## 7.2 The different between subject device and predicate device:
- a) Operational modes
The subject devices have several modes corresponding to the light output intensity and available times. The light output safety and performance test was conducted according to IEC 60601-1, ANSI/ADA specification no.42, ANSI/ADA specification no. 42-2 and FDA guidance performance testing requirements with the difference. The testing results show that these differences do not raise any problems in the safety and performance.
- b) FDA-Recognized Standards Electrical safety & Electromagnetic compatibility
The subject devices accord to new version of Electrical safety & Electromagnetic compatibility Standard; the predicate device was made in 2013, it accorded to old version of Electrical safety & Electromagnetic compatibility Standard.
#### 8. Identification of the risk analysis method
The risk analysis method used to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA). The design verification tests that were performed as a result of this risk analysis assessment are listed as below. The test methods used are the same as those submitted in the original submission.
| Descriptive<br>Information | Test Performed | Acceptance Criteria |
|----------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------------|
| FDA-Recognized<br>Standards:<br>ANSI/ADA<br>Standard No.<br>48-2-2010<br>(R2015) | Ask to Electromagnetic Compatibility test | Pass test and got Verification of<br>Compliance |
| | Ask to Electrical Safety test | Pass test and got Verification of<br>Compliance |
## 9. Performance Testing
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The following tests were conducted to evaluate the functionality, performance and substantial equivalence.
- a) Irradiation (Optical power testing)
- b) Spectral irradiance plot (Wavelength spectrum testing)
- c) Depth of cure (Composite hardness testing)
The tests are in accordance with the following standards:
●American National Standard/American Dental Association (ANSI/ADA) Specification No. 48-2: 2010, Reaffirmed 2015, LED Curing Lights
●American National Standard/American Dental Association (ANSI/ADA) Specification No. 48:
2020, Approved 2020, Curing Lights (Powered Polymerization Activators)
●FDA Guidance for Industry and FDA Staff, Dental Curing Lights -Premarket Notification 510(k) Submissions, Clause 8. Performance Specifications
The test results conformed to the requirements of the standards.
### 10. Conclusion
Validation and verification tests have been conducted to FDA guidance document Dental Curing Lights =Premarket Notification [510(k)]. In comparing between subject device and predicate device, there are the same product code, regulatory classifications for use, light source, power supply, outer casing material, light intensity and peak wavelength of patient contacting portions.
In summary, the WL-120 LED Dental Curing Light in this submission are, in our opinion, substantially equivalent to the predicate device. Safety and performance testing supports substantial equivalence of the subject device to the predicate devices.
